VOLTAREN FORTE 50MG TAB (TABLET)

Dosage / Direction for Use Voltaren Patients w/ established heart disease, uncontrolled HTN, or significant risk factors for CV disease Max: 100 mg daily if treated for >4 wk. Voltaren/Voltaren Forte Adult Initially 100-150 mg/day in 2-3 divided doses. Milder cases & long-term therapy 75-100 mg/day in 2 or 3 divided doses. Primary dysmenorrhea 50-150 mg/day. Initially 50-100 mg, increased over the course of several menstrual cycles. Max: 200 mg/day. Childn ≥1 yr & adolescent 0.5-2 mg/kg/day in 2-3 separate doses. Juvenile RA Up to 3 mg/kg daily, divided into 2-3 separate doses. Max: 150 mg daily. Voltaren SR Initially 100 mg daily. Milder cases & long-term therapy 100 mg daily. Administration Gastro-resistant tab: May be taken with or without food.|SR tab: Should be taken with food: Swallow whole, do not chew/divide. Contraindications Hypersensitivity. Active gastric or intestinal ulcer, bleeding or perforation. Patients in whom the use of acetylsalicylic acid or other NSAIDs can precipitate asthma, angioedema, urticaria or allergic rhinitis (ie, NSAID-induced cross-reactivity reactions). Renal (GFR <15 mL/min 1.73 m2), hepatic & severe cardiac failure. Pregnancy (last trimester). Special Precautions GI bleeding, ulceration or perforation. History of GI toxicity; ulcerative colitis or Crohn's disease. Not recommended for treatment in patients w/ established CV disease (CHF, established ischemic heart disease, peripheral arterial disease) or uncontrolled HTN. Increased risk of serious CV thrombotic events (including MI & stroke). Signs & symptoms of serious arteriothrombotic events (eg, chest pain, shortness of breath, weakness, slurred speech). Patients w/ asthma, seasonal allergic rhinitis, swelling of nasal mucosa (ie, nasal polyps), COPD or chronic resp tract infections (especially if linked to allergic rhinitis-like symptoms), reactions on NSAIDs-like asthma exacerbation, Quincke's edema or urticaria; hepatic porphyria. Hepatitis w/o prodromal symptoms may occur. History of HTN; those w/ substantial extracellular vol depletion. Risk of serious skin reactions including exfoliative dermatitis, Stevens-Johnson syndrome & toxic epidermal necrolysis. Discontinue at the 1st appearance of skin rash, mucosal lesions or any other hypersensitivity. May mask signs & symptoms of infection. Concomitant use w/ corticosteroids, anticoagulants, antiplatelet agents or SSRIs; diuretics, products affecting renal functions. Re-evaluate patient's response if therapy continues for >4 wk. Monitor blood counts; patients w/ hemostasis defect. Hepatic, renal & cardiac impairment. May impair female fertility. Not to be used in pregnancy (1st & 2nd trimester) & lactation. Elderly (frail, low body wt). Voltaren SR Not suitable for childn & adolescents. nteractions Significant increase in peak plasma conc & exposure w/ CYP2C9 inhibitors (eg, voriconazole). May raise plasma conc of lithium & digoxin. May decrease antihypertensive effect of diuretics & antihypertensive agents (eg, β-blockers, ACE inhibitors). May increase nephrotoxicity of ciclosporin & tacrolimus. May increase serum K levels w/ K-sparing diuretics, ciclosporin, tacrolimus or trimethoprim. Convulsions (isolated reports) w/ quinolones. May increase frequency of GI effects w/ other systemic NSAIDs or corticosteroids. May increase risk of bleeding & hemorrhage w/ anticoagulants & antiplatelets. May increase risk of GI bleeding w/ SSRIs. Metabolic acidosis (isolated reports) w/ metformin. Increased exposure w/ phenytoin. May increase blood conc & toxicity of methotrexate (administer <24 hr before or after therapy). Significant decrease in plasma conc & exposure w/ CYP2C9 inducers (eg, rifampicin). Side Effects / Adverse Reactions Headache, dizziness; vertigo; nausea, vomiting, diarrhea, dyspepsia, abdominal pain, flatulence, decreased appetite; increased transaminases; rash.